MINNEAPOLIS — In late April, the University of Minnesota Medical School will join an important Phase III trial for a drug that targets one of the most aggressive and deadly forms of brain cancer.
For Laura Walsh, who has been part of the ongoing Phase II trial, the drug, known as ONC201, has provided two things that once seemed impossible: hope and time.
"The response that we're seeing is truly nothing short of miraculous and we want to keep it going," said Dr. Clark Chen, head of neurosurgery at the University of Minnesota Medical School, who recently helped Walsh mark two years since first taking the drug. "It's important to celebrate this."
Walsh struggled to celebrate anything when she initially joined the trial, because at the time she struggled to remember anything.
"It was awful and it was scary," she said. "I would wake up every day, for a while, not knowing where I was."
Just two weeks after giving birth to her third child in June of 2020, Walsh went to the emergency room while suffering from a debilitating migraine. Scans then revealed that her pain was being caused by a large brain tumor.
"See this ring here, that's Laura's tumor, initially, in 2020," said Dr. Chen, pointing to an early MRI.
After undergoing a biopsy, Walsh learned that she had a tumor known as H3K27 Glioma, a form of brain cancer that is often more aggressive than glioblastoma, while also impacting a much younger population.
"The average survival for a patient who has this cancer is well less than a year," Chen said.
In addition to spreading fast, H3K27 tumors tend to grow near the center of the brain, sometimes spreading down the spinal cord.
For Walsh, the location of the tumor, followed by six surgeries in the first six months of treatment, took a devastating toll.
"We had had our third kid and the first six or seven months, she didn't know who they were," said Keegan Walsh, Laura Walsh's husband. "She kept asking when these parents were going to pick up this kid. You know, it's pretty tough for a new mom to not know who her kid is."
It's pretty tough for a father, too.
Keegan Walsh: "I didn't expect to ask you whether you wanted to die or keep fighting. That's not exactly the conversation you want to have."
Laura Walsh: "It was nothing that I expected in the first 50 years of our marriage, let alone the first eight."
Fortunately, in the past decade, Dr. Chen has helped lead key discoveries into what sets H3K27 apart.
"The neurotransmitters that allow you to communicate with me are also fueling the growth of these brain tumors," Dr. Chen said.
That understanding led to the development of ONC201, which shuts those specific neurotransmitters off.
For Laura, the effect was immediate. Two years after starting the drug, she not only remains alive, she has not required another surgery and her tumor remains a fraction of the size that it once was.
Laura Walsh: "So it's kind of a big deal."
Dr. Chen: "It is a big deal."
Laura Walsh: "And right after our visit, we have another young lady that's getting this drug, and we're hoping that she will have the same response that you will have."
Hoping, because, so far, the drug has been effective for only about one in five patients.
"Even though it only helps 20% of the patients, it is 20% of patients who suffer from a highly aggressive tumor that otherwise have no options," Dr. Chen said.
Even for Laura Walsh, there have still been setbacks. During her most recent visit, they discovered the first potential sign of tumor growth in two years.
Dr. Chen: "We do see these small changes from time to time. Sometimes they go away, but we can't exclude, as you and I talked about, the possibility that this could be tumor growing as well."
Keegan Walsh: "That isn't what you want to hear, but we're doing good. Our degree of good is very different than normal good compared to where we came from. When she didn't know who her daughter was, that was awful, so from that, we feel really good."
The U o fM will join several other sites in launching a phase III trial in late April, with enrollment beginning in May.
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